Chronic obstructive pulmonary disease (COPD), which is also known as chronic obstructive lung disease (COLD), chronic obstructive airway disease (COAD), chronic airflow limitation (CAL), and chronic obstructive respiratory disease (CORD), is a lung disease which primary symptoms include persistent obstruction in the airways, shortness of breath, cough, and sputum production.
COPD is often associated with tobacco smoking and is characterized by inflammation in the airways and a gradual decline in lung function. As the disease progresses during many years, the airway obstruction can become very severe, leading to extreme dyspnea during both exercise and rest and, eventually, lung failure. At this stage, lung function examinations with spirometry usually reveal a loss of lung capacity by 50% or more. Other severe symptoms often appear at this time as well, such as weight loss, depression and cardiac disease. The mortality risk is high in these patients. The established pharmaceutical treatments for these patients are anti-cholinergics, beta2-agonists and steroids, which however normally only give minor improvements. Causing over 3 million deaths in 2011, COPD is ranked as the fourth leading cause of death worldwide (World Health Organization. “The top 10 causes of death”. Fact sheet No 310. July 2013). Due to the aging population mortality is expected to increase in many countries. The economic burden of COPD in the U.S. was estimated at $42.6 billion in health care costs and lost productivity during 2007. Thus, there is urgent need for new and effective treatments for COPD.
Asthma is characterized by chronic inflammation of the airways with mainly reversible airway obstruction and bronchial hyper-reactivity. Asthma is thought to be the result of a combination of genetic and environmental factors. Asthma is usually treatable with steroids and bronchodilators, however, 10% of asthmatics have severe symptoms in spite of maximum treatment. There is also an overlap between COPD and asthma, often rendering a firm diagnosis difficult to obtain (Chang, J.; Mosenifar, Z. “Differentiating COPD from Asthma in Clinical Practice”. Journal of Intensive Care Medicine, 2007, vol. 22, 300-309]).
There have also been reports about obstructive pulmonary diseases, mainly asthma, in animals such as cats and dogs. As in humans, these animals get an obstruction of the airways when the bronchi fill up with mucous and go into spasms (bronchoconstriction). It is far more common in cats than dogs, and particularly in Siamese and Himalayan cat breeds (AnimalHospitals-USA, 2007).
Iodides have been used for many years as expectorants, for instance potassium iodide. However, clinical efficacy of these substances has not been conclusively demonstrated and they may induce thyroid disease (Rogers D F. “Mucoactive drugs for asthma and COPD: any place in therapy?” Expert Opin. Investig. Drugs. 2002 January; 11(1):15-35). Iodinated glycerol has been suggested as a potentially less toxic product, but clinical trials have shown it to lack significant improvement in pulmonary function following 16 weeks treatment with iodinated glycerol. Long term use has also been connected with side effects such as iodine poisoning (Rubin B K. et. al. “Iodinated glycerol has no effect on pulmonary function, symptom score, or sputum properties in patients with stable chronic bronchitis.” Chest. 1996 February; 109(2):348-52).
Iodine is a vital element found in two hormones in humans; thyroxine (T4) and triiodothyronine (T3). They stimulate the body including growth and development. Iodine is actively pumped into the thyroid cells by the sodium/iodide symporter (also called iodide pump or Na+−I− pump) and T4 and T3 regulate metabolism. Furthermore, it has recently been shown that the active uptake of iodide in the intestine is caused by this pump. “Am J Physiol Cell Physiol. 2009 April; 296(4):C654-62. doi: 10.1152/ajpcell.00509.2008. The sodium/iodide symporter is also responsible for absorption of iodide in the kidney, which prevents loss of iodide in the urine.
Activated carbon is known for treating poisoning and as an adjunct to diet for occasional diarrhoea. Medical coal efficiently binds a large number of toxins and may thus prevent harmful substances such as pharmaceuticals, chemicals and bacterial toxins into the body. Activated charcoal has a very large surface area; 1 gram has a surface area of 300-2000 m2 (GREENWOOD, N. N. et. al. “Chemistry of the Elements” Pergamon Press 1984). The term activated carbon also comprises what is meant by the term activated charcoal. Impregnated activated charcoals are carbonaceous adsorbents which have chemicals finely distributed on their internal surface. The impregnation optimizes the existing properties of the activated charcoal giving a synergism between the chemicals and the charcoal (Carbo Tech-Aktivkohlen GmbH. Franz-Ficher-Weg, vol. 61, D-45307, Germany).
It has been shown that iodinated activated charcoal (IAC) can improve lung function on patients with COPD (Skogvall). In EP 2 222 314 B1 is disclosed a method of treating COPD by using iodine on activated carbon. The iodinated activated carbon is administered orally, and it is shown that the carbon or iodine alone does not improve the lung function. Only when iodine was adsorbed on the activated charcoal was there an improved lung function.
Recently, a “Proof of concept” clinical study has confirmed the positive effects by IAC on the lung function of COPD patients, with a significant improvement of the pulmonary function (FEV1 baseline, Forced Expiratory Volume in 1 second) in patients who received IAC, but not placebo. However, the improvement of lung function was only moderate (average 8.2% better than placebo after the 8 week treatment).
It was felt that it should be possible to improve the lung function even further, and it was therefore examined if additional substances could improve the lung function even more.